---
title: "MHRA SaMD & AI Change Program — KYE Protocol™ coverage"
description: "MHRA SaMD & AI Change Program coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it."
url: https://kyeprotocol.com/compliance/mhra-samd-change-programme/
lang: en
source: "KYE Protocol"
---

> MHRA SaMD & AI Change Program coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.

MHRA SaMD & AI Change Program

# MHRA SaMD & AI Change Program — 100% of in-scope requirements covered.

41 requirements · 41 in scope (41 enforced). The 100% is weighted over the in-scope base.

**Source:** MHRA Software and AI as a Medical Device Change Program (2023) — 15 work-packages covering qualification, classification, PCCP, clinical evidence, post-market scrutiny, transparency, bias, cybersecurity, real-world performance, AI Airlock, adaptive control, failure-mode analysis

## By category

| Category | Reqs | Enforced | Designed | Advisory | Deferred | Coverage |
| --- | --- | --- | --- | --- | --- | --- |
| Change-Class Triggers | 9 | 9 | 0 | 0 | 0 | **100%** |
| Software and AI as Medical Device Change Program | 15 | 15 | 0 | 0 | 0 | **100%** |
| Oversight + Bias Mitigation | 4 | 4 | 0 | 0 | 0 | **100%** |
| Predetermined Change Control Plan (PCCP) | 7 | 7 | 0 | 0 | 0 | **100%** |
| Transparency Obligations | 6 | 6 | 0 | 0 | 0 | **100%** |

## Every requirement → the KYE™ artefact that enforces it

| ID | Title | Status | KYE™ enforcement |
| --- | --- | --- | --- |
| `mhra-samd-change-programme.cct.intended-purpose-shift` | Change-class trigger — material shift in intended purpose | enforced | **audit\_events**: `kye.purpose.permission.v1`, `kye.agency_drift.event.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/12-PURPOSE-PERMISSION.md` |
| `mhra-samd-change-programme.cct.capability-expansion` | Change-class trigger — capability expansion beyond declared profile | enforced | **audit\_events**: `kye.model.capability_profile.v1`, `kye.agency_drift.event.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/25-EDGE-GOVERNANCE.md` |
| `mhra-samd-change-programme.cct.model-parameter-drift` | Change-class trigger — model\_params drift beyond envelope | enforced | **audit\_events**: `kye.evidence.model_params.v1`, `kye.model.influence_envelope.v1`, `kye.signal.drift.detected.v1` **engines**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.cct.training-data-shift` | Change-class trigger — training data distribution shift | enforced 1 unverified citation | **audit\_events**: `kye.signal.stable_drift.detected.v1`, `kye.assurance.model_validation.v1` unverified citation **engines**: `internal`, `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.cct.performance-degradation` | Change-class trigger — performance degradation past threshold | enforced 1 unverified citation | **audit\_events**: `kye.signal.drift.detected.v1`, `kye.assurance.review_cycle.v1` unverified citation **engines**: `internal`, `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.cct.indication-expansion` | Change-class trigger — clinical indication or patient population expansion | enforced | **audit\_events**: `kye.purpose.permission.v1`, `kye.risk_assessment.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/12-PURPOSE-PERMISSION.md` |
| `mhra-samd-change-programme.cct.algorithm-architecture-change` | Change-class trigger — architectural change (model type swap, weights replacement) | enforced | **audit\_events**: `kye.evidence.model_params.v1`, `kye.compliance.attestation.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.cct.dataset-bias-shift` | Change-class trigger — bias profile shift across subgroups | enforced 1 unverified citation | **audit\_events**: `kye.assurance.model_validation.v1` unverified citation, `kye.signal.drift.detected.v1` **engines**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.cct.deployment-region-shift` | Change-class trigger — deployment region / jurisdiction change | enforced | **audit\_events**: `kye.jurisdiction.attestation.v1` **engines**: `internal` **constitution\_refs**: `constitution/25-EDGE-GOVERNANCE.md` |
| `mhra-samd-change-programme.wp-1.scope` | Scope of AI/ML as SaMD declared | enforced 1 unverified citation | **audit\_events**: `kye.assurance.model_validation.v1` unverified citation **engines**: `internal` **governedui\_modules**: `kye.governedui.module.entity_passport.v1` **constitution\_refs**: `constitution/36-GOVERNEDUI.md` |
| `mhra-samd-change-programme.wp-2.qualification` | Software qualification (is it a medical device?) | enforced 1 unverified citation | **audit\_events**: `kye.risk_assessment.v1`, `kye.assurance.model_validation.v1` unverified citation **engines**: `internal`, `internal` **dictionaries**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.wp-3.classification` | Classification (Rule 11 SaMD) | enforced | **audit\_events**: `kye.risk_assessment.v1` **engines**: `internal`, `internal` **dictionaries**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.wp-4.pccp` | Predetermined Change Control Plan (PCCP) declared | enforced 2 unverified citations | **audit\_events**: `kye.assurance.adoption_stage.v1`, `kye.assurance.model_validation.v1` unverified citation, `kye.assurance.management_review.v1` unverified citation **engines**: `internal`, `internal` **governedui\_modules**: `kye.governedui.module.action_approval.v1` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.wp-5.change-control` | Change-control evidence (what can change without re-assessment) | enforced 2 unverified citations | **audit\_events**: `kye.assurance.adoption_stage.v1`, `kye.resilience.drift.detected.v1` unverified citation, `kye.assurance.management_review.v1` unverified citation **engines**: `internal`, `internal` **workers**: `kye-drift-detector` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.wp-6.clinical-evidence` | Clinical evidence (sufficient, current, representative) | enforced 2 unverified citations | **audit\_events**: `kye.evidence.pack.v1`, `kye.evidence.healthcare.cdss.v1` unverified citation, `kye.assurance.model_validation.v1` unverified citation **engines**: `internal`, `internal` **workers**: `kye-evidence-pack-assembler` **sector\_packs**: `kye:sector-pack:healthcare` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-samd-change-programme.wp-7.post-market-scrutiny` | Post-market scrutiny (continuous monitoring) | enforced 3 unverified citations | **audit\_events**: `kye.resilience.drift.detected.v1` unverified citation, `kye.resilience.measurement_record.v1` unverified citation, `kye.report.quarterly_drift.v1` unverified citation **engines**: `internal`, `internal`, `internal` **workers**: `kye-drift-detector`, `kye-reporting-worker` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.wp-8.transparency-explainability` | Transparency and explainability | enforced | **audit\_events**: `kye.evidence.decision_map.v1`, `kye.evidence.pack.v1` **engines**: `internal`, `internal` **governedui\_modules**: `kye.governedui.module.evidence_timeline.v1` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.wp-9.human-interpretation` | Human-interpretation support | enforced 1 unverified citation | **audit\_events**: `kye.decision.record.v1`, `kye.consent.receipt.v1` unverified citation **engines**: `internal` **governedui\_modules**: `kye.governedui.module.critical_point_review.v1` **constitution\_refs**: `constitution/36-GOVERNEDUI.md` |
| `mhra-samd-change-programme.wp-10.bias-fairness` | Bias-and-fairness considerations | enforced 1 unverified citation | **audit\_events**: `kye.risk_assessment.v1`, `kye.resilience.drift.detected.v1` unverified citation **engines**: `internal`, `internal` **constitution\_refs**: `constitution/20-ANALYTICS-PLANE.md` |
| `mhra-samd-change-programme.wp-11.cybersecurity` | Cybersecurity of AI-SaMD | enforced 1 unverified citation | **audit\_events**: `kye.audit.event.v1`, `kye.audit.event.appended.v1` unverified citation **engines**: `internal`, `internal`, `internal` **workers**: `kye-gateway`, `kye-audit-chain-worker` **probes**: `security-headers`, `tls-valid` **constitution\_refs**: `constitution/30-AUDIT-WORM-RETENTION.md` |
| `mhra-samd-change-programme.wp-12.real-world-performance` | Real-world-performance monitoring | enforced 3 unverified citations | **audit\_events**: `kye.resilience.measurement_record.v1` unverified citation, `kye.report.monthly_decision_summary.v1` unverified citation, `kye.report.quarterly_drift.v1` unverified citation **engines**: `internal`, `internal` **workers**: `kye-reporting-worker` **constitution\_refs**: `constitution/20-ANALYTICS-PLANE.md` |
| `mhra-samd-change-programme.wp-13.ai-airlock` | AI Airlock alignment (regulatory sandbox) | enforced | **audit\_events**: `kye.decision.shadow_evaluation.v1`, `kye.assurance.adoption_stage.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.wp-14.adaptive-algorithm-control` | Adaptive-algorithm change control | enforced 2 unverified citations | **audit\_events**: `kye.assurance.adoption_stage.v1`, `kye.resilience.drift.detected.v1` unverified citation, `kye.assurance.model_validation.v1` unverified citation **engines**: `internal`, `internal` **workers**: `kye-drift-detector` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.wp-15.failure-mode-analysis` | Failure-mode analysis | enforced 1 unverified citation | **audit\_events**: `kye.assurance.threat_model.v1` unverified citation, `kye.risk_assessment.v1`, `kye.assurance.audit_replay_report.v1` **engines**: `internal`, `internal` **agents**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.ob.subgroup-performance` | Subgroup performance reporting (age, sex, ethnicity, comorbidity) | enforced 1 unverified citation | **audit\_events**: `kye.assurance.model_validation.v1` unverified citation, `kye.evidence.pack.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.ob.bias-mitigation-plan` | Bias mitigation plan + ongoing fairness monitoring | enforced 1 unverified citation | **audit\_events**: `kye.signal.drift.detected.v1`, `kye.assurance.review_cycle.v1` unverified citation **engines**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.ob.human-in-the-loop-at-critical-point` | Human-in-the-loop required at clinical critical points | enforced | **audit\_events**: `kye.governedui.critical_point_review.v1`, `kye.governedui.approval.v1` **engines**: `internal` **constitution\_refs**: `constitution/36-GOVERNEDUI.md` |
| `mhra-samd-change-programme.ob.override-capture` | Capture clinician override + dissent | enforced | **audit\_events**: `kye.evidence.observed_action.v1`, `kye.governedui.critical_point_review.v1` **engines**: `internal` **constitution\_refs**: `constitution/36-GOVERNEDUI.md` |
| `mhra-samd-change-programme.pccp.declared-changes` | PCCP — declared adaptive-algorithm changes (scope envelope) | enforced | **audit\_events**: `kye.model.capability_profile.v1`, `kye.model.influence_envelope.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/12-PURPOSE-PERMISSION.md` |
| `mhra-samd-change-programme.pccp.modification-protocol` | PCCP — modification protocol describing data/test/release criteria | enforced 1 unverified citation | **audit\_events**: `kye.assurance.model_validation.v1` unverified citation, `kye.evidence.pack.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.pccp.impact-assessment` | PCCP — impact assessment for each declared change | enforced | **audit\_events**: `kye.risk_assessment.v1`, `kye.evidence.decision_map.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.pccp.outside-scope-trigger` | PCCP — change outside declared envelope triggers re-approval | enforced | **audit\_events**: `kye.agency_drift.event.v1`, `kye.compliance.attestation.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/25-EDGE-GOVERNANCE.md` |
| `mhra-samd-change-programme.pccp.version-traceability` | PCCP — version traceability across change instances | enforced | **audit\_events**: `kye.compliance.attestation.v1`, `kye.evidence.pack.v1` **engines**: `internal` **constitution\_refs**: `constitution/25-EDGE-GOVERNANCE.md` |
| `mhra-samd-change-programme.pccp.transparency-disclosure` | PCCP — disclosed to users + Approved Body before deployment | enforced | **audit\_events**: `kye.transparency.statement.v1`, `kye.comms.dispatched.v1` **engines**: `internal` **constitution\_refs**: `constitution/38-COMMS-RAIL.md` |
| `mhra-samd-change-programme.pccp.ongoing-monitoring` | PCCP — ongoing performance monitoring after each declared change | enforced | **audit\_events**: `kye.signal.drift.detected.v1`, `kye.evidence.observed_action.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.tr.user-facing-disclosure` | User-facing transparency — clinician sees that AI is in the loop | enforced | **audit\_events**: `kye.transparency.statement.v1`, `kye.transparency.receipt.v1` **engines**: `internal` **constitution\_refs**: `constitution/36-GOVERNEDUI.md` |
| `mhra-samd-change-programme.tr.confidence-disclosure` | Confidence + uncertainty disclosed alongside output | enforced | **audit\_events**: `kye.evidence.decision_map.v1`, `kye.transparency.statement.v1` **engines**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-samd-change-programme.tr.training-data-summary` | Training data summary published in model passport | enforced | **audit\_events**: `kye.model.capability_profile.v1`, `kye.transparency.statement.v1` **engines**: `internal` **constitution\_refs**: `constitution/17-DIRECTORY-SEARCH.md` |
| `mhra-samd-change-programme.tr.limitations-published` | Known limitations + contraindications published | enforced | **audit\_events**: `kye.transparency.statement.v1` **engines**: `internal` **constitution\_refs**: `constitution/17-DIRECTORY-SEARCH.md` |
| `mhra-samd-change-programme.tr.change-log-public` | Public change log of declared modifications | enforced | **audit\_events**: `kye.compliance.attestation.v1`, `kye.transparency.statement.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/25-EDGE-GOVERNANCE.md` |
| `mhra-samd-change-programme.tr.user-recourse` | User recourse — clinician can override + flag concerns | enforced | **audit\_events**: `kye.governedui.critical_point_review.v1`, `kye.evidence.observed_action.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/36-GOVERNEDUI.md` |

Canonical KYE™ surfaces referenced on this page: [KYE Protocol™](https://kyeprotocol.com/).